Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- wheelchair independence and mobility
研究概览
简要总结
Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of medical complications; or to improve the mobility. The restrictive autonomy is due to different factors: firstly wheelchair users reduce their movement because they need technical or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs. Without specific practice, the upper limbs mechanical and physiological properties do not permit exercises that are long and intense. Then, the purpose of this research is to evaluate the effects of an 8 weeks interval training program on wheelchair independance during inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to a control group (classical rehabilitation program in a physical medicine and rehabilitation department).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute spinal cord injury (SCI) from trauma , medical or surgical pathology at levels between C7 and L
- •Categories A or B as defined by the American Spinal Injury Association (ASIA) Impairment Scale
- •Male or female
- •18 to 60 years old.
- •No ability to walk independently with or without an assistive device
- •3 to 6 months post-SCI in early phase of rehabilitation in a physical medicine and rehabilitation unit.
- •Subject affiliated to a social security regime and registered at the healthcare department
- •Written informed consent obtained from each subject
排除标准
- •Symptomatic syringomyelia that may complicate the evaluation procedures
- •Disabled pathology before the SCI
- •Cardiopulmonary disease, degenerative disorders, upper limb disorders, bones inury or other significant medical complications that would prohibit or alter compliance with a wheelchair training protocol.
- •Psychological incapacity to follow a training protocol during 8 weeks.
- •Surgery or intrathecal injection planned.
- •Reject to give written informed consent.
结局指标
主要结局
wheelchair independence and mobility
时间窗: inclusion and 6 month
adapted 6-minutes walk test (maximal distance ran in 6 minutes with patient's personal wheelchair) crossing a 5% slope functional independence measure (FIM) quality of life
次要结局
- Cardiovascular parameters(inclusion and 6 month)
- Biomechanic parameters during manuel wheelchair propulsion(inclusion and 6 month)